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临床试验/NCT07410871
NCT07410871已完成不适用

Degenerative Spondylolisthesis Accompanying LSS: Do We Need Fusion?

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
1
主要终点
Assessment of low back pain

研究概览

简要总结

This study aimed to compare clinical results of decompression alone using minimal invasive unilateral laminotomy for bilateral decompression versus classical decompression and instrumentation and fusion.

详细描述

The term "lumbar spinal stenosis" (LSS) describes the anatomical narrowing of the spinal canal, which occurs in older people because of spinal ageing.

Initial treatment is usually medical. Surgical management is recommended for patients with failed non-surgical trials. As claudication is always the main complain, lumbar canal decompression is the traditional surgical treatment.

Although adding instrumentation and fusion is not uncommon and widely used. In the literature, the benefit of fusion, is treating instability that causes degenerative spondylolisthesis, improve back pain if present, and avoid slippage progression, which possibly will occur with generous decompression and disruption of the posterior column.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 50 years.
  • Both sexes.
  • Patients with symptoms of lumbar spinal stenosis (LSS) (neurogenic claudication) confirmed by magnetic resonance imaging (MRI), and a degenerative spondylolisthesis measuring at least 3 mm at the stenotic level on a plain X-ray.

排除标准

  • Patients with excessive foraminal stenosis (a deformed nerve root in the intervertebral foramen).
  • Thoracolumbar scoliosis of greater than 20 degrees.
  • Patients with significant instability in plan radiography dynamic study.
  • Patients who had previous spine surgery at lumbar region.

研究组 & 干预措施

Group 1 (Unilateral laminotomy decompression)

Patients underwent unilateral laminotomy decompression.

干预措施: Unilateral laminotomy decompression (Procedure)

Group 2 (Decompression and fusion)

Patients underwent a posterior decompression, (either with or without preservation of midline bands) was followed by instrumentation using pedicle screws with rods and intervertebral fusion device.

干预措施: Decompression and fusion (Procedure)

结局指标

主要结局

Assessment of low back pain

时间窗: 14 months after the procedure

Low back pain was assessed using the Oswestry Disability Index (ODI), 10-question self-report questionnaire to measure functional disability and quality of life. It yields a percentage score from 0% (no disability) to 100% (severe disability).

次要结局

  • Degree of pain(14 months after the procedure)
  • Incidence of complications(14 months after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Mohamed Basha

Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.

Kafrelsheikh University

研究点 (1)

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